Label: NUVALU EPSOM SALT (magnesium sulfate- heptahydrate granule

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated December 17, 2019

If you are a consumer or patient please visit this version.

View All Sections
  • DRUG FACTS

  • Active Ingredients

    Magnesium sulfate (heptahydrate) 100%

  • Purpose

     Saline laxative

  • Uses

    • For relief of occasional constipation (irregularity)
    • This product generally produces bowel movement in 30 mins to 6 hours
  • Warnings

    Ask a doctor before use if you have

    • Kidney disease

    • A magnesium restricted diet

    • Abdominal pain, nausea or vomiting

    • Notice a sudden change in bowel habits that persists over a period of 2 weeks

    • Already used a laxative for a period longer than 1 week

    Ask a doctor or pharmacist before use if you are

    taking any other prescription drugs. Laxatives may affect how other drugs work

    If pregnant or breast-feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

  • Directions

    • Do not exceed more than 2 doses per day
    • Drink a full glass (8 ounces) of liquid with each dose
    • Dissolve the dose in 8 ounces of water.
      Lemon juice may be added to improve the taste.
    adults and children 12 years and over2 to 4 level teaspoons
    (10 to 20 grams) daily 
    children 6 to under 12 years1 to 2 level teaspoons
    (5 to 10 grams) daily
    children under 6 yearsconsult a doctor

  • Other Information

    • magnesium content 493 mg per teaspoon (5 grams)
  • Inactive Ingredients

    none 

  • SPL UNCLASSIFIED SECTION

    UNSCENTED

    MULTI-PURPOSE

    Natural magnesium sulfate crystals

    Use as a saline laxative

    Package sold by weight not volume. Some settling of content may occur during shipment. If caking occurs, tap pouch gently to free granules.

    Distributed by JC Sales,

    Los Angeles, CA 90058

    Made in China

  • Packaging

    Epsom002

  • INGREDIENTS AND APPEARANCE
    NUVALU EPSOM SALT 
    magnesium sulfate (heptahydrate) granule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72520-002
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MAGNESIUM SULFATE HEPTAHYDRATE (UNII: SK47B8698T) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM SULFATE HEPTAHYDRATE100 g  in 100 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72520-002-12454 g in 1 BAG; Type 0: Not a Combination Product11/30/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart33411/30/2018
    Labeler - J C SALES (610969578)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!